Institutional Review Board (IRB) Documentation

What documents are required for a complete IRB application?

  1. Application Form. See below to determine which of the four types: Fast-Track Exempt Classroom B-1; Fast-Track Survey/Interview B-2; General Application for Exemption; Non-Exempt Application.
  1. Documentation of Faculty Approval. If you are a STUDENT, you must provide documentation that your faculty advisor (1) has read your IRB application, and (2) approves of the research as proposed.  This can be sent through e-mail by the faculty advisor to IRB@udayton.edu.
  2. Documentation of Off-Site Approval.  If you will be collecting data OFF-CAMPUS, you must provide documentation of approval by a site administrator (e.g., school principal, facility director). This can be sent by e-mail to IRB@udayton.edu.
  3. Consent Document. All human research requires obtaining consent from your participants. There are several types of consent documents. Please see below for a discussion of consent documents.  Please be sure to use the correct format – if you are not sure, contact us for guidance at IRB@udayton.edu.
  1. Study-specific Instruments. A list of survey or interview questions, questionnaires, data collection sheets, evaluative or diagnostic instrument, or debriefing protocol designed specifically for this research.
  1. Recruitment Advertisement.  Please include the ads, brochures, or script to be used to recruit participants to your study. 

THE IRB CANNOT REVIEW APPLICATIONS UNTIL ALL PARTS OF THE APPLICATION PACKAGE HAVE BEEN SUBMITTED.

How do I know which application form to use for my research?

It is critical that students work closely with their faculty advisor to design their research projects in such a way that risk is minimized to human participants.  Your faculty advisor can assist you in determining which form to use to seek IRB approval.  Questions should be directed to IRB@udayton.edu.

  1. B-1 Fast-Track Exempt Classroom Research Application Form: This form may be used by researchers who want to conduct research in established or commonly accepted educational settings, involving only normal educational practices (regular or special education instructional strategies, effectiveness of instructional techniques, curricula, classroom management methods). This application form may NOT be used if the research is sponsored with federal funds, or if compensation is involved. See “How to Apply” for guidance if your study will use drawings, raffles, compensation, or incentives.

  2. B-2 Fast-Track Exempt Survey/Interview Research Application Form: This form may be used by researchers who want to conduct anonymous paper surveys, confidential online surveys, or non-sensitive interviews using only adult subjects. Non-sensitive refers to topics and content that would not be considered embarrassing or that would not have a negative impact on a subject’s employability or reputation. This application form may NOT be used if the research is sponsored with federal funds, if prison populations are used, if compensation is involved, or if minors under the age of 18 are involved. 

If your project does not fit the description above for the Fast-Track application forms, you should use the appropriate general exempt application form or the non-exempt application form. 

  1. General Application for Exemption: This form is appropriate for federally funded classroom research, surveys, or non-sensitive interviews with adult subjects. This form can also be used for classroom research, surveys, or non-sensitive interviews with adult subjects when compensation or incentives are offered.
  2. Non-Exempt Application: This form should be used for all other types of research. 

If you are not sure which form to use, or if you review any of the application forms and have questions, please contact us at IRB@udayton.edu.  WE WELCOME YOUR QUESTIONS!

What types of consent document or process should I use for my research?

All human research requires obtaining consent from your participants and the consent process must involve the researcher communicating a specific set of key features of the study to a potential participant. Many studies require documentation of this consent through signed consent forms. To ensure your consent form is complete and correct, please use one of TEMPLATES provided here. 

FOR USE WHEN HUMAN SUBJECTS ARE AT LEAST 18 YEARS OLD:

  1. Invitation-to-Participate-in-Research for Fast-Track Exempt B-2 Studies using Surveys or Non-sensitive Interviews.  For use with online surveys or exempt-fast-track interviews, the researcher should use an Invitation-to-Participate document in lieu of collecting signatures. If the research is not eligible for the Fast-Track form, please contact us to see if this method of consent is acceptable.
  2. Full length consent document. This document should be used for all NON-EXEMPT human research.  There are templates for full length, traditional consent documents for both Social Science-Behavioral Science studies, and for Biomedical studies.

FOR USE WHEN HUMAN SUBJECTS ARE LESS THAN 18 YEARS OLD:

  1. Parental Consent document. For any research involving subjects under the age of 18, the researcher should use the Parental Consent document.
  2. Parent Information Sheet for Fast-Track Exempt B-1 Studies in the Classroom. Under certain circumstances for classroom research, with a school principal’s permission, the Parent Notification Sheet can be used in lieu of a signed parental consent form.   If the research is not eligible for the Fast-Track form, please contact us to see if this method of consent is acceptable.
  3. Child Assent Form. For research involving subjects under the age of 18, in combination with the Parental Consent document, a Child Assent form can be used.

Some other forms you might need for human subjects research:

Request for Renewal of Approval - All approved non-exempt research protocols are under “continuing review” by the IRB.  This means the IRB retains oversight of the study until the study is officially closed. Please use this form If you are applying for a renewal of an already approved protocol.

Human Research Closure of Study Form – All non-exempt research studies remain under IRB continuing review until the study is officially “closed.”  It is the responsibility of the researcher to notify the IRB that the study is closed. Please submit this form to close your study.

Adverse Event Report – To learn about adverse events and unanticipated problems in human research, please visit: http://www.hhs.gov/ohrp/policy/advevntguid.html

HIPAA Authorization Form for disclosure of medical information - Authorization for Use or Disclosure of Protected Health Information, as required by the Health Insurance Portability and Accountability Act ---- 45 CFR Parts 160 and 164.  To learn more about HIPAA, visit: http://www.hhs.gov/ocr/privacy/

All application materials should be sent to IRB@udayton.edu. All questions can be directed to Dr. Mary Connolly, IRB Chair, IRB@udayton.edu, or (937) 229-3493.